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Embolic Protection Device Set for Clinical Trials

Originally Published MPMN June 2003

INDUSTRY NEWS

Embolic Protection Device Set for Clinical Trials

A small-profile embolic protection filter is designed to allow the capture and removal of dislodged embolic material during cardiovascular interventions.

An embolic protection filter that will soon undergo clinical trials in Germany garnered a great deal of attention at the 52nd annual Scientific Session of the American College of Cardiology in Chicago at the end of March. The Rubicon Filter, developed by Rubicon Medical Corp. (Salt Lake City; www.rubiconmed.com) was highlighted in three separate sessions at the conference. The device figured prominently in a paper on acute myocardial infarction presented by Eberhard Gruber, who introduced the concept that the filter could be effective in the treatment of this condition. Gruber is the chief of cardiology at the Heart Center in Siegburg, Germany, and has been retained by Rubicon as the principal investigator for the upcoming clinical study. The device was also mentioned in an overview of currently approved and investigational devices, as well as a presentation on vein graft intervention.

Described by the firm as the world's smallest embolic filtration device, the Rubicon filter is designed to capture material dislodged in the bloodstream during cardiovascular interventions. It has the potential to prevent a heart attack or stroke while permitting the continuous flow of blood through the affected vessel or artery.

Resembling a miniature windsock, the filter is deployed by means of a 0.14-in.-thick guidewire. Following the surgical procedure, the filter is closed and removed with the aid of a catheter.

Clinical advantages of the product, according to Rubicon, include a low crossing profile and no bench preparation requirements. In addition, the filter can be deployed outside the body in less than one second, and the use of a catheter is not required to unsheathe the device. This enables physicians to easily and accurately steer and manipulate the filter inside an artery.

The filter is currently in the final stage of the design phase. Rubicon hopes to obtain CE marking for the device by the end of 2003, which will allow the filter to be marketed throughout the European Union. Clinical trials are also imminent at several dozen U.S. hospitals. The company has not yet determined the specifics of how the filter will be distributed once it has achieved market clearance.

Copyright ©2003 Medical Product Manufacturing News

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